A Phase 2, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants with Type 1 Diabetes Mellitus
Protocol Number: CT-868-004
Sponsor: Carmot Therapeutics
The current treatment paradigm for T1DM, focuses exclusively on glycemic control via insulin therapy and fails to address, and in fact exacerbates issues of high insulin concentrations in the blood, insulin resistance and weight gain. In the last decade, a paradigm shift has occurred in the treatment of patients with Type 2 diabetes mellitus (T2DM) using adjunctive therapies with SGLT-2 inhibitors and GLP-1. Large cardiovascular disease outcome trials have shown a reduction in cardiovascular disease risk that is not attributable to glycemic control alone. Adopting a similar approach that addresses the treatment of overweight and obese patients living with T1DM is overdue.
Summary of Study Details:
This study consists of 12-13 bi-weekly office visits with phone calls in between to monitor progress and make insulin adjustments over the course of approximately 25 weeks (about 5 and a half months). You will be randomly assigned to 1 of 4 treatment arms with doses from 1.8mg to a max dose of 6.6 mg depending on tolerability. Your chances of getting active study drug are 75%. Chances of being assigned to placebo are 25%.
Each office visit will include procedures to monitor your health such as physical exams, blood pressure measurements, and ECGs at several of the visits. A DEXA bone density scan will be performed at the beginning and end of the study.
You will be provided with a glucometer, test strips and a ketone meter with strips. And will also be asked to maintain an electronic study diary on your smartphone to capture daily study dosing, symptom information and your insulin usage during the Run-in and Treatment Periods. During some visits, patient questionnaires will capture how you feel about your health.
Compensation includes a patient stipend of $150 per visit, totaling $1800-$1950 upon completion of the trial. If you discontinue the trial, you will be paid for visits completed.
General Eligibility Criteria:
- Age 18-65
- BMI ≥ 27kg/m2
- A1c 7-10%
- Must be treated with insulin through manual CSII pump or Multiple Daily Injections with basal/bolus insulin for at least 12 mo. stable regime for 2 months prior to Screening. There are no closed loop pumps permitted.
- Non-smoking for at least 6 months prior to Screening
- Must not have hypoglycemic unawareness
- Must not have gastrointestinal absorption or motility issues
- Must not have used GLP-1 (Ozempic, Wegovy, Mounjaro, Victoza, etc) or SGLT-2 (Jardiance, Farxiga, Invokana, etc) or other adjunctive treatments for diabetes other than insulin for at least 6 months prior to Screening. Site will review other prohibited medications that could cause an issue with eligibility.
- Must have experience wearing a Continuous Glucose Monitor (CGM) within the 3 months before Screening and be willing to wear a study supplied Dexcom G6 for duration of the study.
If interested in learning more, please contact our Research Coordinator, Jamie Sigg, RD,CDCES, CRC at (303) 321-2644 x 214